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A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B contact lens with color, automated
Lotrafilcon B contact lens with color, semi-automated
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Myopia focused on measuring myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able and willing to sign a written Informed Consent form.
  • Cylinder ≤ -0.75 diopter (D).
  • Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25.
  • Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
  • Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
  • Pathologically dry eye.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto

    AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto

    Arm Description

    Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.

    Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.

    Outcomes

    Primary Outcome Measures

    Overall satisfaction
    The participant was asked, "Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses." Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied.

    Secondary Outcome Measures

    Overall lens fit
    Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
    Overall lens fit
    Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
    Contact Lens Corrected Visual Acuity (CLCVA)
    CLCVA (corrected distance monocular visual measurement in normal illumination) was tested for each eye individually while wearing study lenses. Participant read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.
    Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)
    As tested for each eye individually while wearing study lenses. Participant will read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.

    Full Information

    First Posted
    June 5, 2012
    Last Updated
    May 3, 2017
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01614678
    Brief Title
    A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens
    Official Title
    AIR OPTIX® COLORS: Automated vs Semi-automated Manufacturing Processes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CIBA VISION

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    myopia

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto
    Arm Type
    Other
    Arm Description
    Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.
    Arm Title
    AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto
    Arm Type
    Other
    Arm Description
    Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B contact lens with color, automated
    Other Intervention Name(s)
    AIR OPTIX® COLORS
    Intervention Description
    Silicone hydrogel contact lens with color manufactured via an automated process
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B contact lens with color, semi-automated
    Other Intervention Name(s)
    AIR OPTIX® COLORS
    Intervention Description
    Silicone hydrogel contact lens with color manufactured via a semi-automated process
    Primary Outcome Measure Information:
    Title
    Overall satisfaction
    Description
    The participant was asked, "Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses." Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied.
    Time Frame
    Week 2
    Secondary Outcome Measure Information:
    Title
    Overall lens fit
    Description
    Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
    Time Frame
    Dispense (Day 0)
    Title
    Overall lens fit
    Description
    Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
    Time Frame
    Week 2
    Title
    Contact Lens Corrected Visual Acuity (CLCVA)
    Description
    CLCVA (corrected distance monocular visual measurement in normal illumination) was tested for each eye individually while wearing study lenses. Participant read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.
    Time Frame
    Dispense (Day 0)
    Title
    Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)
    Description
    As tested for each eye individually while wearing study lenses. Participant will read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight.
    Time Frame
    Week 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able and willing to sign a written Informed Consent form. Cylinder ≤ -0.75 diopter (D). Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25. Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses. Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator. Pathologically dry eye. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sharon Holden Thomas, O.D.
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens

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